ExtenDATEâ„˘ Sterility Testing System

The ExtenDATEâ„˘ is a complete, USP<71>-compliant sterility-testing solution for Small-Volume Parenteral (SVP) Compounded Sterile Products (CSPs) that are not inhibitory and do not produce cloudiness or precipitates.** Used in accord with the comprehensive process setup and control, and the compounding instructions provided, this new product quickly and easily assures the USP<797>-compliant compounding of 40-200 mL CSP batches, confirmed by USP<71>-compliant sterility testing of these products. The instructions and guidelines included allow the hospital and clinical pharmacy to safely and cost-effectively prepare complete SVP batches in-house, with the maximum expiration dating to extend the usability and availability of these products, without the need for any outside vendors. SteriMSâ„˘ and ThioMSâ„˘, the revolutionary new USP<71>-compliant products that comprise the ExtenDATEâ„˘ Sterility Testing System, are also available separately in packages of 12.

** In order to test small-volume CSPs containing penicillins or cephalosporins using USP<71> methods, an appropriate quantity of of pre-assayed, sterile Beta-lactamase may be aseptically added to the sample Piggy-back source container prior to obtaining the test sample in order to inactivate the antibiotic action, thus removing any antibiotic inhibition of the test. One source of B-lactamase in a convenient, sterile form is: http://www.agscientific.com/lactamase.html. In this manner, the broadest range of small-volume CSPs possible may be assayed as appropriate to extend expiration dating.